Spinal Cord InjuriesNCT04949763
Reliability and Validity of the ISNCSCI in Patients With Non-traumatic Spinal Cord Lesions
An observational study of Spinal Cord Injuries, run by I.R.C.C.S. Fondazione Santa Lucia.
Trial summary
Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- rehabilitation
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with non traumatic spinal cord lesions
Who may be able to join
- having a non-traumatic SCI
- acute / subacute phase
- any level and severity (ASIA Impairment Scale) of injury
- having a cognitive status that allows collaboration in the exam.
Who cannot join
- presence of dementia or cognitive decline;
- having a pathology of the peripheral nervous system that may affect the evaluation of ISNCSCI;
- having a multiple sclerosis
About this study
Official title: Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions
Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.
Read the detailed description
All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been prospectively enrolled in the study.
- Conditions
- Spinal Cord Injuries
- Being tested
- rehabilitation
- Keywords
- non traumatic spinal cord injury, ISNCSCI, inter-rater reliability, rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
Patients underwent ususal rehabilitation treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Interanational Standards for Neurological Classification of Spinal Cord Injury
standards to evaluate neurological status of subject with spinal cord injury
Measured: 1 year
Secondary outcomes (1)
Spinal Cord Independence Maesure
Outcome measure to evaluate the independence in daily life activities for subjects with spinal cord injury
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jan 2017
- Primary completion30 Jun 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Scivoletto, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949763
- Sponsor's protocol ID
- CE/PROG.838 29-05-20
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be available upon reasonable request
Publications
Rupp R, Biering-Sorensen F, Burns SP, Graves DE, Guest J, Jones L, Read MS, Rodriguez GM, Schuld C, Tansey-Md KE, Walden K, Kirshblum S. International Standards for Neurological Classification of Spinal Cord Injury: Revised 2019. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):1-22. doi: 10.46292/sci2702-1. No abstract available.
PubMed 34108832
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions
- ClinicalTrials.gov ID
- NCT04949763
- Acronym / sponsor ID
- CE/PROG.838 29-05-20
- Conditions
- Spinal Cord Injuries
- Keywords
- non traumatic spinal cord injury, ISNCSCI, inter-rater reliability, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.
Detailed description
All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been prospectively enrolled in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with non traumatic spinal cord lesions
Key inclusion criteria (4 listed)
- having a non-traumatic SCI
- acute / subacute phase
- any level and severity (ASIA Impairment Scale) of injury
- having a cognitive status that allows collaboration in the exam.
Key exclusion criteria (3 listed)
- presence of dementia or cognitive decline;
- having a pathology of the peripheral nervous system that may affect the evaluation of ISNCSCI;
- having a multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitationPatients underwent ususal rehabilitation treatment | Other | – |
Primary outcome
Interanational Standards for Neurological Classification of Spinal Cord Injury
Time frame: 1 year
standards to evaluate neurological status of subject with spinal cord injury
1 secondary outcome
Spinal Cord Independence Maesure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 34108832Rupp R, Biering-Sorensen F, Burns SP, Graves DE, Guest J, Jones L, Read MS, Rodriguez GM, Schuld C, Tansey-Md KE, Walden K, Kirshblum S. International Standards for Neurological Classification of Spinal Cord Injury: Revised 2019. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):1-22. doi: 10.46292/sci2702-1. No abstract available.
- Individual participant dataSharing planned: No. Anonymized data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by I.R.C.C.S. Fondazione Santa Lucia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interanational Standards for Neurological Classification of Spinal Cord Injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.